医疗器械口咽通气道产品注册的常见问题及改进建议

近年来,医疗器械口咽通气道产品的注册数量日益增加,针对该产品的相关咨询也逐渐增多。但该产品暂无相关的注册技术审查指导原则,以致该产品的注册申报资料经常出现一些共性问题。现根据医疗器械口咽通气道产品相关法规和标准,对日常工作中遇到的常见问题进行归纳,分析该产品注册申报中的技术审评要求及共性问题,并给出对策或建议。

Common Problems in Registration of Oropharyngeal Airway for Medical Devices and Suggestions for Improvement

The registration of oropharyngeal airway products for medical devices is increasing,and the related consultation for this product is also increasing.However,the product has no relevant registration technology review guidelines,so that the product registration declaration data often have some common problems.According to the relevant regulations and standards of the products of oropharyngeal airway of medical devices and the common problems encountered in the author’s participation in the evaluation of such products in Henan Province,this paper summarizes the technical evaluation requirements and common problems in the registration declaration of the products,and gives relevant countermeasures or suggestions.